CancerPhase 3NCT00199602
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
A Phase 3 study testing warfarine - low molecular heparin in people with Cancer, run by University Hospital, Limoges at 1 site in France.
Trial summary
This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients). Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- warfarine - low molecular heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteFrance
- Study dates
- Aug 1999to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First line chemotherapy for solid tumor with:
- Metastatic disease or
- Involved nodes or
- Unresectable tumor
- Indication for Implantable device for central venous access
- Potential survival > 3 months
Show all 11Show fewer
- ECOG performance status 0 to 2 (WHO)
- Age between 18 and 75 years.
- Social security guaranteed
- Normal laboratory assessments (platelets> 100000/mm3, TP 60%, spontaneous TCA with M/T<1.5, TGO and TGP < 2xN, serum creatinin<120µmol/l)
- Informed consent signed
Who cannot join
- Inability to understand informed consent or interfering with compliance for treatment or protocol Anti-coagulant treatment -related criteria
- Acute infectious endocarditis
- History related with heparin allergy or thrombopenia due to heparin
- Uncontrolled high blood pressure (systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg)
- Hemorrhagic syndrome ongoing
- Patient with platelet inhibitors treatment
Show all 11Show fewer
- Chronic, daily treatment with anti-coagulant therapy (LMWH or AVK), use as preventive or curative level
- Patient with liver failure (TP<60%) or renal insufficiency (creatinin clearance< 20 ml/mn)
- Women with pregnancy and lactating Pathology-related criteria
- deep venous thrombosis history or pulmonary embolism (< 6 months)
- Clinical suspicious of brain metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study
This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients).
Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months
- Conditions
- Cancer
- Being tested
- warfarine - low molecular heparin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarine - low molecular heparinDrug
| Study group | Role | What they receive |
|---|---|---|
| lack of drug prophylaxis | No intervention | Not described |
| HBPM 2500 UI anti Xa in one subcutaneous injection per day | Experimental | Not described Receives: Drug: warfarine - low molecular heparin |
| warfarine 1mg daily | Experimental | Not described Receives: Drug: warfarine - low molecular heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the prevalence of symptomatic or asymptomatic deep venous thrombosis in cancer patients with implantable device for central venous access with or without prophylaxis :
Measured: Day90
Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy
Measured: Day90
Secondary outcomes (6)
- Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -
Measured: Day90
- Frequency of other symptomatic venous thromboembolic events between 3 groups.
Measured: J0, J1, J21, J42, J63 and J90
Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose
Measured: Day90
-Costs in the 3 strategies
Measured: J90
- Tumoral response to chemotherapy in the 3 groups.
Measured: Day90
- Overall survival in each group.
Measured: Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 1999
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole TUBIANA-MATHIEU, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199602
- Sponsor's protocol ID
- I99006
- Status last verified
- Dec 2008
- First submitted
- 14 Sep 2005
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lavau-Denes S, Lacroix P, Maubon A, Preux PM, Genet D, Venat-Bouvet L, Labourey JL, Martin J, Slaouti P, Tubiana-Mathieu N. Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study. Cancer Chemother Pharmacol. 2013 Jul;72(1):65-73. doi: 10.1007/s00280-013-2169-y. Epub 2013 May 1.
PubMed 23636449
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study
- ClinicalTrials.gov ID
- NCT00199602
- Acronym / sponsor ID
- I99006
- Conditions
- Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Aug 1999 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients).
Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lack of drug prophylaxis | No intervention | – |
| HBPM 2500 UI anti Xa in one subcutaneous injection per day | Experimental | Drug: warfarine - low molecular heparin |
| warfarine 1mg daily | Experimental | Drug: warfarine - low molecular heparin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- First line chemotherapy for solid tumor with:
- Metastatic disease or
- Involved nodes or
- Unresectable tumor
- Indication for Implantable device for central venous access
Key exclusion criteria (11 listed)
- Inability to understand informed consent or interfering with compliance for treatment or protocol Anti-coagulant treatment -related criteria
- Acute infectious endocarditis
- History related with heparin allergy or thrombopenia due to heparin
- Uncontrolled high blood pressure (systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg)
- Hemorrhagic syndrome ongoing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warfarine - low molecular heparin | Drug | HBPM 2500 UI anti Xa in one subcutaneous injection per day, warfarine 1mg daily |
Primary outcome
Evaluation of the prevalence of symptomatic or asymptomatic deep venous thrombosis in cancer patients with implantable device for central venous access with or without prophylaxis :
Time frame: Day90
Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy
Time frame: Day90
6 secondary outcomes
- Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -
Time frame: Day90
- Frequency of other symptomatic venous thromboembolic events between 3 groups.
Time frame: J0, J1, J21, J42, J63 and J90
Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose
Time frame: Day90
-Costs in the 3 strategies
Time frame: J90
- Tumoral response to chemotherapy in the 3 groups.
Time frame: Day90
- Overall survival in each group.
Time frame: Day90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Results publication: PubMed 23636449Lavau-Denes S, Lacroix P, Maubon A, Preux PM, Genet D, Venat-Bouvet L, Labourey JL, Martin J, Slaouti P, Tubiana-Mathieu N. Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study. Cancer Chemother Pharmacol. 2013 Jul;72(1):65-73. doi: 10.1007/s00280-013-2169-y. Epub 2013 May 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole TUBIANA-MATHIEU, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing warfarine - low molecular heparin in people with Cancer, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the prevalence of symptomatic or asymptomatic deep venous thrombosis in cancer patients with implantable device for central venous access with or without prophylaxis : (time frame: Day90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00199602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.